Tell FDA: Supplements are Not Drugs

An FDA supplement policy infringes on free speech and makes it more difficult to study the health benefits of food and food supplements. Help us fight back!

For years, ANH has fought against the federal government’s censorship of free speech about the benefits of food and supplements. One important battle in that war is to stop the FDA from forcing researchers who are studying nutrients to submit investigational new drug (IND) applications, which are costly and burdensome, have stifled important research about the health benefits of nutrients, and in fact can end up turning those nutrients into drugs.

In 2014, the FDA released a guidance that, under certain conditions, required those studying the benefits of supplements to meet the same standards as new drugs. This policy has made it exponentially more difficult to study the many health benefits of vitamins and nutrients.
ANH staff recently met with the FDA to discuss a variety of issues, this flawed guidance among them. Thanks to the grassroots activism of ANH members, FDA staff showed a willingness to re-examine this policy in light of the information ANH presented. To drive the point home, ANH submitted a Citizen’s Petition explaining in detail FDA’s flawed reasoning and requesting the policy be modified.

Here’s how this policy works. If a researcher—be it an academic working at a university or a supplement company—is studying a nutrient for its potential to treat or prevent a disease, an IND application must be filed. This is the process that drug companies must go through to develop new drugs.

Companies are required to submit an IND application if their research could support new health claims or the expansion of existing health claims. Historically, INDs haven’t been required for nutrients or food products because research does not speak to the intended use of the food product.

Requiring IND applications to study supplements is ludicrous. By definition, supplements are not drugs. IND regulations were created as part of the drug approval process, not as a way to regulate the clinical study of foods and dietary supplements. In the IND guidance, FDA explains that an IND is needed if the research involves a drug. As the FDA has made painfully clear in other areas, supplements are not drugs—so IND regulations should not apply to them.

Further, a supplement company may need to conduct a study that investigates a supplement’s ability to diagnose, cure, mitigate, treat, or prevent a disease in order to substantiate a legal dietary supplement claim, like a structure/function claim (e.g. “Helps maintain cholesterol levels already within the normal range”). Yet if such a study conducted under an IND were to be published, according to the letter of the FDA’s policy, the supplement can become a drug. That’s right: by doing the necessary legwork to substantiate a legal dietary supplement claim, the supplement being studied can be turned into a drug if those studies are published, according to the FDA. By putting these barriers in place for companies trying to make legitimate claims, the FDA effectively stymies free speech about the benefits of food and supplements.

This does not apply to dietary supplements and foods “marketed in or as dietary supplements” before October 1994, and there is an exception made for those that came into the market afterwards—as long as the FDA’s “new dietary ingredient” (NDI) protocols have been followed. The problem is that the FDA hasn’t told supplement companies how to comply with these rules yet—the supplement industry has in fact been waiting for 24 years (and counting) for direction from the FDA on this issue.

Not only has the FDA’s IND policy chilled research on food and supplements; it has provided a back channel by which supplements can be turned into drugs. With your help, we can make the FDA change this guidance.

39 responses to “Tell FDA: Supplements are Not Drugs”

Recently, a Bias Pro Big Pharma article has been decimated to all major news outlets and published in the US: The title of the article was “Older Americans are “hooked” on Vitamins” A clever title that insinuates taking Vitamins are like Opioids. In reality, it is a spin article paid and bought for by Big Pharma to discredit vitamin intake: Here is my response to the article:
Why is it the jury is always still out? The attached Nutrient Deficiency chart from USDA in 2009 documents the nutrient deficiencies that exist in the US population due to current factory farming methods and lifestyle issues. Let’s put it into perspective. The US prescription market is about 450 BILLION dollars a year in annual sales. If you are 65 or older, you are in the age group that is taking 225 BILLION dollars a year in Rx drugs. The supplement market is between 15 and 30 Billion depending on what you include. Are there risks to overdosing on vitamins? Absolutely.. Zinc, Vitamin A to name a few. Vitamin D is not in the high risk category. At the same time, the risk of dying from an Rx drug is much greater. Current crisis: Opioids. Nsaids, Psychotropic drugs and many more. The result is that the 3rd leading cause of death in the US is not a disease state, but the allopathic medicine model.
The most intelligent way to handle supplements is to know your deficiencies. Spectracell.com has a nutrient panel of 35 nutrients which will measure your blood value of these nutrients and then you can determine your needs to supplement.
I would rather take a Niacin tablet to control my cholesterol over a statin drug that depletes my body’s store of Co Q 10. Prescription drugs deplete essential nutrients. Check out the book Drug Muggers. Medicine continually ignores the great harm that is created with our current approach to disease treatment in the US.
Vitamin D of course is a no brainer that is the number one travesty of modern medicine not to embrace the concept that all of us from infant on need to have a Vitamin D supplement due to the lifestyle issues that have depleted the body’s stores in the majority of Americans.
Let Food (nutrient rich sources) be your medicine or Medicine ( Rx drugs) will be your Food. I have just completed a 3 hour lecture series on this topic. Happy to present it to any group that has an open mind and is seeking the truth.
Thomas A. Braun RPh N2E+ for Life

I grew up with dogs and cats. I often wondered why they were basically healthy and active all their lives then one day slowed downed and passed peacefully. Years later I learned it was because of their food – heavily supplemented to levels defined by a number of relevant animal health organizations. We should do the same to people – oh wait, silly me, we have pharma drugs, a superior option (SARC SARC SARC).

The GREEDY big pharma isn’t satisfied with killing people; they have included pet animals. You notice that pets are getting the same health problems people are. Part of it is from the pesticide food and the pills from the vet doesn’t help. My dog is losing its hair from the pill the vet gave her, it started to grow back until my spouse went and got her more. He is all for going to doctors & vets and taking presc. drugs. Then again, it could be from all those vaccines which most of them do more harm than good and only a few are necessary, not 5 which my vet gave to my dog today.
Had taken same pills 2 different times, didn’t work then so I made my husband take the new same ones back to vet. Pills to clear an ear infection that keeps coming back? DUH! Going to try the apple cider vinegar or mineral oil instead and I bet it will work better.

Agree 100%! Dogs are getting cancer on their paws from walking on pesticide lawns and at the site of the Frontline topical flea meds! I have been using apple cider vinegar in his food and also citrus on his coat. My previous vet got irritated when I told them that I didn’t want to use Frontline on my baby kitten. They are realizing that we aren’t putting up with this nonsense any longer. There are titer tests that you can get as well which will tell you if your animal is still protected. Good luck with your pup. I hope he gets to feeling better soon!

THANK you for this straightforward, easy to digest (no pun intended, maybe), overview and awesome advice! Sheesh…. I spend WAY too much time, distracted by overly complicated, purposely vague, by pretentious so called experts who try to frighten us away from just plain common sense advice in how to remain healthy/vibrant/active ‘seniors’…. Can’t get used to calling myself a senior just yet – because I don’t really feel ‘older’ but without really knowing what older feels like I might be missing something? Anyway, I attribute my continued quality of life to listening to my body-I don’t consume regular doses of most vitamins/supplements- ‘D’ is one of them, along with a baby aspirin, and if I succumb to one or more of my granddaughters colds she so generously shares with us, I make teas from various plants, mostly found right around the house. We could eat more healthy foods-I try to stick to as much fresh/unprocessed meals/snacks-but since moving back to WV from NC it’s a challenge-WV’s economy and support for small farms, food crafters, and herbalists is limited…but we do the best we can…. And all of this seems to be working for me…. I read and research when there is a need, I’m an herbalist by necessity…. So, with this said, again, thank you, your information is greatly appreciated.

To add, I would like to see more naturalist doctors and researchers support the movements to protect what we have left of our natural forests/grasslands/prairies… From hardrock mining to fracking-pipelines, salvage logging, wood pellets for biomass from hardwood forests in the southeast, to tree plantations in Brazil for pulp, and conversion from natural to industrial for any purpose, we are loosing the places where a great deal of our best food/medicine is found. I appreciate emphasis / importance of getting as much of the nutrients we need from food, and warning us about the ills of industrial agriculture. Would like to see more about how ‘weeds’ are valuable sources of nutrients, and add; ‘so stop pouring weed killer on them’. Would like to see a little more support on protecting the plant/tree nations, the wild places that have been our grocery store and pharmacy for thousands of years………thanks for reading.

“… we are losing the places where a great deal of our best food/medicine is found.” Yes, and those habitats that have not been cleared for profit are being attacked with poisons, especially the heavy metals and chemicals from geoengineering.

Knowledgeable people (scientists) and companies who try to educate their consumers about nutrient deficiencies, get their products forcefully banned from the market under the guise that those sold nutrients are “drugs by definition.” This false and deceptive categorization exempts the FDA from following the confines of the Dietary Supplement Health and Education Act of 1994 (DSHEA) which clearly states that the FDA cannot remove a product from the market unless they can show harm or danger to the consumer. The FDA is a fraudulent organization, period.

Why has this not been challenged in the court? Too expensive? The FDA is a passive governmental agency that is guided by Big Pharma in their role to protect Americans from harm. They are not proactive and an independent agency that is truly required to change the current medical paradigm. The current case in point is the FDA’s passive role in the opioid crisis.

In 1988, the FDA recognized that foods (nutrients) can reverse disease states:
Medical foods are foods that are specially formulated and intended for the dietary management of a disease that has distinctive nutritional needs that cannot be met by normal diet alone.
In the United States they were defined in the FDA’s 1988 Orphan Drug Act Amendments and are subject to the general food and safety labeling requirements of the Federal Food, Drug and Cosmetic Act.
In Europe the European Food Safety Authority established definitions for “foods for special medical purposes” (FSMPs) in 2015.
So, they ignore their own rules about the fact that foods (which are really nutrients) can
reverse disease states???

We were sued. We fought with 5 attorneys. We lost. Nearly 2 million dollars in products expired. I had already paid for the
labor and ingredients to manufacture those. That broke me financially. I have spent nearly 4 years trying to get someone to take notice of the FDA’s unlawful practices. My congressman, my senators, the President, the Vice President, news outlets, etc. No one cares when it does not affect them. The Alliance for Natural Health would not even tell my story (and I had donated to them for years prior.). The fighter in me finally gave up after petitioning the federal judge for relief. The judge denied us relief this year. Although the business closed, my husband and I are still forbidden to sell ANY brand of dietary supplemnt. WE ARE BANNED. It will take the closing of a BIG supplement company for anyone to take notice and care. My made in the USA supplements are gone forever. Good luck everyone else.

I’m sorry for the stress you and your husband have experienced. I’ve spent the last ten years trying to educate people who will listen that most of their disease states can be reversed with life style changes including the consumption of good food. The problem is that most Americans have nutrient deficiencies and don’t know it. It means we should all be tested for blood value of key nutrients and supplement accordingly. Intimidation (FDA police is a re-enforcer) is the name of the game and the FDA is a tool of Big Pharma. Senator Durbin is a good example why nothing will change. J&J loaned a senior staff employee to be his Health Administrative Aide. I meet her 20 years ago. His learned his medicine views from J&J which is shaping what is transpiring today. I bet you didn’t have a lawyer named Eliott.

Thats the stupid and greedy govt., politicians, doctors & big pharma for you.
They know nothing about nutriient cause they can’t make money off it or get their pockets padded. Even a doctor doesn’t take a nutrional class in med school. Sorry to hear about your lose….corrupt govt.

Medical foods are foods that are specially formulated and intended for the dietary management of a disease that has distinctive nutritional needs that cannot be met by normal??? diet alone.
In the United States they were defined in the FDA’s 1988 Orphan Drug Act Amendments and are subject to the general food and safety labeling requirements of the Federal Food, Drug and Cosmetic Act. In Europe the European Food Safety Authority established definitions for “foods for special medical purposes” (FSMPs) in 2015.

ELEMENTARY BASIC KNOWLEDGE ON NATURE’S SOURCES OF LIFE, VITALITY AND HEALING, IS MISSING IN ALL ESTABLISHED FIELDS OF OUR RESEARCH AND EDUCATION. OUR BODIES ARE DESIGNED BY NATURE NOT BY MEDICAL SCIENTISTS.. WE NEED TO GROW A NEW GENERATION OF LEARNING CONSUMERS AND LEARNING MEDICAL PROFESSIONALS, INDEPENDENT FROM ANY INDUSTRIES!!! OTHERWISE WE ARE DOOMED, AS WE ARE NOW BRAINLESSLY MANIPULATED BY HIGHLY IGNORANT, MORONIC SYSTEMS, ENDLESSLY QUESTIONABLE PAID BY INDUSTRIES CORRUPTED “LAB RESEARCH” AND THE FOLLOWING DEADLY POISONOUS MEDICAL DRUGS&TREATMENTS ADVERTISEMENT. CHEERS!

The question is the legitimacy of this agency altogether.Not all their researchers are bribable.The research of those for instance who document.the dangers of psychdrugs is swept under the rug totally and a considerable number of FDA approved drugs and vaccines have caused major damage.to people ,including death.How can such.a government.department claim any credibility and authority at all.?Before anyone continues to.bow down to their rules and regulations or ask for new ones,the DOJ should look into.their legitimacy to.start with !

The USA has a very high infant mortallity rate compared to other industrial nations that don’t require 20-30 shots for them. Also, the mercury in many of those shots have mercury in it and has caused autism to rise dramatically here but not there.

Supplements aren’t drugs – the are concentrates of food nutrition, and should not require IND application. Ridiculous red tape and regulations designed to make Big Pharma money, not to help
nourish lives.

The FDA did indeed close down my dietary supplement manufacturing facility almost 4 years ago. We contacted you, ANH, to run our story, but you would not because you thought we might be “guilty.” My husband (our supplement formulator) was told to submit new drug applications, but since the ingredients are all listed as dietary supplement ingredients, he would not. Our products were labeled “drugs by definition” and removed from the market. We are banned from selling any brand of dietary supplement. https://bioanuehealth.com/pressrelease-stopmonster.html

So sorry to hear this. I read just recently that Big Pharma is paying the FDA’s salaries, that is a conflict of interest. The FDA is supposed to be there to protect us , but that is not what is happening. In the last few years around 15 + natural cure DR.s have died mysteriously. Have any of you seen the articles about President Reagan going to Germany for cancer treatment, look it up, this cure has been around since 1944. Our country has known since 1925 that sugar feeds cancer, and they didn’t tell anyone for years. My brother-in-law had lung cancer a few yrs. ago and the Dr.s had him go on a total sugar free diet, only using Stevia and his cancer was gone in 6-8 weeks.

My brother-in-law went to the same type of clinic as Reagan did except it was in Rosarita Beach in Baja Calif. Drs. gave him 3 yrs. and/or another 5 yrs to live before dying from cancer. That was 18 yrs. ago and his cancer cancer never came back and it was cured within 2-3 weeks and cost only $18,000. Kaiser hospital paid him $30,000 as they were afraid he would sue them.

I like what everyone had to say, we do need some over site to make sure that the companies are putting what they say in their product, just not the FDA. In the last few years they have figured out a lot of the natural cures from the Bible, here some of it has been mistranslated. It has been very interesting. You know the Chemistry chemical chart, the gold section is all healing elements.

These liars are the Father of Lies. Endless propaganda, misinformation, and fraudulent science used to create fear, or false security in their dangerous concoctions pimped as medicine…..The health of our citizens has been undermined for decades by their abuses of the public!
We live long and strong, with quality of life without their poisons….common sense which all of us are given by God, sadly have been hypnotized right out of the culture by their marketing tactics and pimping medical establishment who no longer practices “Medicine”. Yet all the innovative, toxic free, risk free, methods are demonized and condemned.

I have been alarmed over Consumer Report’s articles on supplements. It would appear that they do extensive research on cars, vacuums, smart TVs, and diapers. For supplements it seems they just call up a shill, unknowing or not, for Big Pharma.
Between the FDA, USDA, the AMA, and the pharmaceutical industry, there is a putsch to remove as many healthful options as possible.

When reading about drugs, NEVER believe a study done by Big Pharma or the fda. It never reports anything bad enough about the drugs so it gets refused. If an independant study is done against the drug, it is usually swept under the rug; make sure they have no ties to big pharma.

Millions of people a year die from wrong diagnosis and the wrong medications. Over diagnosed, under diagnosed. How dare you want to take away my choices. I do not want to take medications at all. Instead, I choose to go the most natural way possible and so many other people think exactly like I do. Big Pharma does not want to see people take herbs, supplements and why is that? Because we will get well, sure it may take a bit longer. So much better then your big pharma pills.

At age 75, my sister at 81, take no drugs and haven’t done so in many ???? years yet the stupid obamacare forces me to have a prescription plan I don’t use; otherwise I pay a penalty…Hail Hitler…telling me what to do. (My younger sister who took 4-5 presc. drugs, died from organ failured caused by Big Pharma…talk about drug pushers and killers. They pad the pockets of politicians, the fda and doctors so they can push their drugs onto people and kill over 100,000+ people a year with their drugs which don’t cure people but just puts a leaky bandage over it so they have to come back for another bandaid. Once they get you hooked, many drugs once started, you can’t get off of them unless you want to die. The opiods is a good example.. And they bitch about vitamins and herbs….how dumb can they be. I know more people who died from their drugs and none who died from natural supplements. I can relate a dozen examples of people, including myself, that have solved health issues naturally. All the way from my high cholesterol to my brother-in-laws cancer. It is all about the money and the greed of Big Pharma , politicians & doctors. How can these people look at themselves in the mirror knowing that they are killing people, and kids, with their poisonous drugs. What a big cartel they are.; and they talk about the illegal drug cartels? DUH!

Supplements have been used for longer than the FDA has been around. Turning the definition into “drugs” in order to take control of this is a stupid and obvious means of giving yet MORE control of our health to the pharmaceutical industry — which is concerned only with profit, not health. Yet another example of corporate greed wrecking America.

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